104 CHAPTER 5 Effectiveness of MR compared to UC Primary outcome Absolute and adjusted group means for SRQ-DLV outcomes at different time points (T0T1) are presented in Table 2. At T1 the group means adjusted for sex, age and baseline SRQ-DLV values were 61.92 (95% CI: 55.52-68.33) for the UC group and 70.53 (95% CI: 65.25-75.80) for the MR group, with a significant mean group difference of 8.60 (95% CI: 0.26-16.94) (F(x,y) = 4.414, p = 0.044). Because of baseline difference in ‘time since onset NA’, we performed a post-hoc ANCOVA with time since onset NA as additional covariate with no difference in outcome (F(x,y) = 4.457 p = 0.043). The proportion of participants who attained the minimal clinical important difference on the SRQ-DLV score (≥ 12 points) at T1 was larger for the MR group (13/22; 59%) than UC group (5/15; 33%) (Fisher’s exact test: p = 0.184), resulting in an absolute risk reduction of 26% (95% CI:-6-58%). The number needed to treat is 4, this means that about one in every four patients will benefit from the MR. Secondary outcomes Absolute and adjusted group means for all secondary outcome measures at different time points (T0-T1) are presented in Table 3A+B. The group means adjusted for age, sex and baseline values at T1 showed a significant difference in favor of the MR group for the USER-P subscale 3, satisfaction with current daily life activities (F(x,y) = 6.072, p = 0.019). In addition, a significant difference in favor of the UC group was found for the pinch grip measurement (F(x,y) = 2.372, p = 0.025). No other group differences were found to be significant. Retention of effects Primary outcome The mean SRQ-DLV score at the end of the MR for all participants combined (MR group (T1) and UC group (T2), n = 34) was 69.41 (95% CI: 62.41-75.31) versus 71.69 (95% CI: 65.14-77.24) at follow-up (mean difference 2.28, 95% CI: -1.68-6.23). This means that over a 18 week follow-up period after the MR there is a retention of the effect on the functional capability of the shoulder, arm and hand. Secondary outcomes There were no significant time effects during 18 weeks of follow-up in any of the secondary outcome measures (Supplementary Table 3).
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